Company Info

Our Team

Risk Management Programs

Automated Software Solutions Take the Hassle and Confusion out of Risk Management Programs

Effective evaluation and management of risk is the most effective means a company has of gauging compliance while minimizing costs. The trick, however, is implementing a cohesive risk management program that eliminates-rather than contributes to-system-wide uncertainty. Automated risk management programs allow companies to closely monitor critical events and better measure the effectiveness of corrective actions.

Reducing Risk with Automated Risk Management Programs

The main reason organizations are making the shift to electronic solutions for their risk management systems is because they need a central hub for all risk-related activities and documentation. Software solutions that automate risk management programs can give companies a complete and accurate picture of the risk landscape across product lines, business processes, and business units while also helping companies avoid reputation damage, recalls, or regulatory action that may come from ignoring risk factors.

In situations where assessments are performed but not standardized, risk evaluations will inevitably vary from one assessor to the next. Consequently, whether or not appropriate follow-up actions are taken will be dependent on the individual assessor, which means similar issues may end up being dealt with inconsistently. Implementing a consistent risk management program throughout the enterprise can help avoid such pitfalls.

Connecting Risk Management Programs on an Enterprise Level Ensures that All Departments are Working in Unison

If a risk system isn't cohesive, it may as well not even exist. When a single enterprise-level risk management program is in place to monitor and manage risk management activities, it guarantees that corporate risk tolerance thresholds are employed and followed organization-wide for all actions pertaining to risk management. Comprehensive and integrated risk management gives employees from different departments a uniform and efficient means of participating in risk assessment and mitigation activities. If you are considering automating your risk management, make sure that it offers all the built-in capabilities your organization will need, such as electronic workflows and electronic signatures for execution, review, and approvals and similar functionality. Also take into account the risk management program's ability to leverage a risk-based approach in multiple processes (i.e., CAPA, non-conforming material disposition, protocol development, supplier qualification, etc.)

Don't forget: streamlining processes and automating risk management sounds great on paper, but if you aren't able to implement effective changes and report on the resulting data it's like driving as fast as you can with your eyes closed. Any risk management program worth its salt must include adequate analytics reporting features that allow for comprehensive analysis of risk files and risk assessments. Risk processes that offer scheduled reporting capabilities and intelligent threshold rules are even more helpful (not to mention that they make the bosses happy by increasing management awareness of and visibility into risk-related activities).

What to Look for in a Risk Management Program

Homogeny: Above all, a risk management program should be uniform and connected throughout the organization. Quality and regulatory departments need standardized methods and tools to conduct consistent risk analyses. Likewise, engineering and manufacturing personnel should be able to easily document and store risk mitigation activities in product and process design.

Comprehensive Management Oversight: A risk program's standard methodology should simplify the application of resources in the organization's most risk-prone areas. Always keep in mind (management does!) that the underlying purpose of the risk program should be to ensure that organizational risk tolerance is not exceeded.

Useful Risk Assessment Capabilities: An effectual program should allow users to configure multiple risk types for evaluating different categories of operational risk. Take into account, for instance, whether or not the access provided to the software will allow for risk assessments to be launched electronically from any location. In short, risk management programs that incorporate best practice processes will be better suited to analyze hazards associated with any process or activity and should incorporate risk mitigation and reassessment.

Effective Risk File Management: Risk software should provide a single collection point for all risk-related activities relevant to a given project, process, supplier, etc., thereby unifying all risk assessments, documentation, and other risk management processes.

Additional Information about Risk Management Programs

For more information about risk management programs and the risk management software offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

Software Magazine ranks MasterControl 369 on its 2014 Software 500 list, a listing of the world's largest software and services providers. Now in its 32nd year, the Software 500 is a revenue-based ranking of vendor viability. Learn More